Optimized pH and local enzymatic metabolisms (e.g., metabolizing and transporting enzymes) can be critical to the absorption and activity of a specific drug or medicament. It is well known that drug metabolizing and drug transporting enzymes can be enhanced or inhibited within the lining of the gut wall. For example, it has been shown that grapefruit can inhibit the absorption of many drugs up to 8 to 12 hours after intake. Similarly, milk has been shown to reduce absorption and transportation of some antibiotics. Many foods likewise decrease the rate of absorption of acetaminophen and thereby reduce its analgesic affect. However, some beverages have been known to speed up the rate of absorption of acetaminophen and thereby increase its analgesic affect.
Many drugs or medicaments are not well tolerated when administered enterally. For example, aspirin, ibuprofen, and naproxen are known to irritate the stomach. In order address these problems, physicians may recommend that certain drugs be taken with food to improve tolerance. However, each drug has a specific pH of absorption, and the food intake recommended by a physician for improving tolerance can significantly alter the absorption, transport and/or bioavailability of the drug. For example, high fiber foods may bind to a drug and prevent its absorption. If the coating on a tablet or capsule is not subject to the appropriate environment, it may not dissolve as intended, thus causing the drug within the tablet or capsule, or a significant portion thereof, to pass directly to the feces. On the other hand, particularly in children, diarrhea may speed up the dissolution of tablets or capsules, and may thereby prevent the drug from achieving an expected therapeutic effect.
Although it would be desirable to mix drugs and beverages in the same packages or dispensers in order to enhance drug tolerance, and/or to enhance drug absorption, transport and/or bioavailability, many such drug/beverage combinations are not believed to be shelf stable, and/or are not approved for combination by the United States Food and Drug Administration (“FDA”) or other applicable regulatory agencies.
Many reconstitution packages have been made in different fields of use, including pharmaceuticals. A typical reconstitution package allows the manufacturer to fill two different active ingredients in different compartments of a common package such that each compartment is approved for stability of the respective ingredient. This can be a significant advantage where the two active ingredients are not shelf stable when combined. Typically, the user mixes or “reconstitutes” the two active ingredients immediately prior to ingestion. The present inventor is not aware of any reconstitution packages including a drug or medicament in one compartment and a food or beverage in another compartment. One possible reason for this is that drugs, on the one hand, and foods and beverages, on the other hand, are subject to different regulatory requirements, such as those imposed by the FDA. Foods and beverages are frequently enriched solutions or suspensions, and in many cases have low levels of acidity, and thus frequently provide excellent media for bacterial and/or yeast growth. As a result, the FDA and other applicable regulatory agencies impose limited shelf life and period of use restrictions on such food and beverage products unless they are terminally sterilized. Terminal sterilization typically involves the application of radiation, such as gamma or ebeam radiation, or the application of heat, such as by retort. For many drugs, however, terminal sterilization is not possible because it would either destroy or damage the active ingredients. Accordingly, typically there are substantial differences between the aseptic processes and equipment used to manufacture drugs in comparison to those for foods and beverages. Similarly, there can be substantial differences in the FDA and other applicable regulations for the manufacture of drugs in comparison to those for foods and beverages.
Accordingly, it is an object of the present invention to overcome one or more of the above described drawbacks and/or disadvantages of the prior art.